MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 1.5T
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our field service engineer went onsite to confirm that the issue emanated from the 3rd party uninterruptible power supply model riello mst 125.He also confirmed that there was no malfunction or otherwise involvement of our magnetic resonance imaging device.As an immediate containment the 3rd party ups was disconnected and bypassed, so the mains power supply could remain connected to the mri system, and the mri system was then fully functional again.In terms of corrections, the 3rd party ups supplier (b)(4) was informed by the customer to come onsite to initiate the repair of the impacted ups damaged parts, and to make the ups functional again.The supplier (b)(4) will take further investigative and where required corrective actions to resolve this issue.This is the 2nd time we have encountered this kind of issue with this model mst 125 ups from riello.A previous incident was reported to you via mdr 3003768277-2023-05179.
Event or Problem Description
Philips received a report of a malfunction of a riello uninterruptible power supply that is connected to the mri system.This resulted in a lot of thick smoke emanating from the ups.There was no malfunction or involvement of the mri, however, out of an abundance of caution, it was decided to report this.

• Brand Name: INGENIA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 20638605
• Report Number: 3003768277-2024-06174
• Device Sequence Number: 7404369
• Product Code: LNH
• UDI-Device Identifier: 00884838099043
• UDI-Public: 00884838099043
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: INGENIA 1.5T
• Device Catalogue Number: 782115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown